Comparison Thymoglobulin® and Grafalon®

Renal Transplantation Clinical Trial

— THYGRET  

Official title:

Comparison Thymoglobulin® Versus Grafalon® in Renal Transplantation - Spiesser Group (Retro/Prospective Study) I

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03996278
• Other study ID #: 29BRC19.0018
• Status: Recruiting
• Start date: May 22, 2019
• Est. completion date: November 22, 2021

Study information

• Verified date: June 2020
• Source: University Hospital, Brest
• Contact: Yannick LE MEUR
• Phone: 298-347-074
• Email: yannick.lemeur[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, multicenter, observational, non -interventional study with comparison with an historical cohort Investigators will compare the efficacy and safety of Thymoglobulin (Sanofi-Aventis) versus Grafalon (Neovii, previously ATG-Fresenius) in renal transplantation by evaluating patient survival, graft survival, delayed graft function, acute rejection, DSA occurrence and toxicities, various infections including CMV and BK virus incidence, MACE (major cardiac adverse event) and cancer.

Investigators will also compare cumulative treatment and follow up costs and other key criteria available in the ASTRE database.

Description:

This is a prospective, multicenter, observational, non -interventional study with comparison with an historical cohort Investigators will compare the efficacy and safety of Thymoglobulin (Sanofi-Aventis) versus Grafalon (Neovii, previously ATG-Fresenius) in renal transplantation by evaluating patient survival, graft survival, delayed graft function, acute rejection, DSA occurrence and toxicities, various infections including CMV and BK virus incidence, MACE (major cardiac adverse event) and cancer.

Investigators will also compare cumulative treatment and follow up costs and other key criteria available in the ASTRE database.

Justification for a non-interventional study: in the study the medicinal products will be prescribed in the usual manner in accordance with the terms of the marketing authorisation. The assignment of the patient to the product is not decided in advance by a trial protocol but falls within current practice of the centre and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures are applied to the patients and epidemiological methods are used for the analysis of collected data.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 22, 2021
• Est. primary completion date: May 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• For the Grafalon prospective group: all first 11-12 patients from the 13 transplant centres receiving Grafalon according to the local practice

• For the Thymoglobulin group: a group of 130 patients matched for:

age (donor and recipient) gender indication (immunological indication versus DFG) CMV status

Exclusion Criteria:

• Patient younger than 18 years old

• Living donor

• Donor after cardiac death (because the Maastricht 3 donors are authorized recently in France)

Related Conditions & MeSH terms

• Renal Transplantation

Intervention

Other:
• Grafalon
None interventional study but there are two groups

Locations

Country	Name	City	State
France	CHU Amiens Picardie, Hopital Sud	Amiens
France	CHU d'Angers	Angers
France	CHRU de Brest	Brest
France	CHU Hopital Clemenceau	Caen
France	CHU Hopital Gabriel Montpied	Clermont-Ferrand
France	CHU Dupuytren 2	Limoges
France	Hopital Necker Enfant Malade	Paris
France	CHU La Milétrie	Poitiers
France	CHU Hopital Maison Blanche	Reims
France	CHU de Rennes	Rennes
France	CHU Hopital de Bois Guillaume	Rouen
France	Hopitaux Universitaires de Strasbourg - Hopital civil	Strasbourg
France	CHRU de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison adverse events of the 2 ATGs and data collected thanks to the ASTRE database	All events: Death, graft loss, acute rejection, DGF, de novo DSA Severe infection (SAE), hematological adverse event (SAE), CMV infection, BK virus infection, MACE(major cardiac adverse event) and cancer	During one year
Secondary	Recipient Efficacy (any adverse events)	comparison during the first year between the two groups for: patient and graft survival, delayed graft function, one year rate of acute rejection, occurrence od de novo DSA, renal function at one year (eGFR,MDRD)	During one year
Secondary	Recipient Safety (any adverse events)	Comparison during the first year between the two groups for various infections (virus, bacteria, fungi), hematological adverse event (SAE or not)	During one year
Secondary	Reconstitution of the T, and B cell populations	Reconstitution of the T, and B cell populations at D0, D7, M3, M12	During one year
Secondary	Cost comparison	Hospitals costs at 1 year months (including re-hospitalisation costs)	During one year